15 Amendments of Jessica POLFJÄRD related to 2021/2013(INI)
Amendment 43 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas a competitive and innovative pharmaceutical industry is of vital importance for the Union's public health, economic growth, science base and ability to create jobs and drive technological progress;
Amendment 50 #
Motion for a resolution
Recital B
Recital B
B. whereas COVID-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats, more European integrcooperation and coordination is necessary; whereas a European Health Union, which contributes to an increasingly social Unionthese objectives, is key in this process;
Amendment 55 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas healthcare is a national competence and thus an area over which Member States have ultimate responsibility;
Amendment 202 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to incorporate newstrengthen the criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls onemphasizes that EU funding should be steered towards projects where research is needed the most; invites the Commission to promoevaluate the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;
Amendment 241 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, andhow to ensure a resilient, diversified and sustainable value chain that meets that delivers on the Member States' healthcare objectives and meets the primary and broader needs of the population;
Amendment 260 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system, increase price transparency, highlight the causes limiting affordability and patient access towork with Member States and relevant Union and Member State agencies to assess the root causes of shortages of pharmaceuticals and medicinal products, within the Union; and propose sustainable solutions that also promote competition and preserves and strengthens the Union's strong basis for innovation;
Amendment 290 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines andEmphasizes that competition leads to lower prices and greater affordability; calls on the Commission to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industrytake action that promotes research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines, emphasizes that such proposals must respect the individual needs and preferences of patients and their clinicians;
Amendment 352 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. StressNotes the importancvalue of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needs; stresses that such joint procurement initiatives should be undertaken only under exceptional circumstances and in situations where such action has a clear and demonstrable added value, such as serious cross-border health threats;
Amendment 388 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive; welcomestakes note of the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems;
Amendment 420 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can only thrive globally with a clear, robust and efficient intellectual property system and that the framework for intellectual property must therefore be protected and preserved; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;
Amendment 521 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, nanomedicines, next- generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 549 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines and evaluate how further regulatory flexibilities, including for GMO medicinal products, could contribute to a more efficient authorisation system; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU, including a shift towards electronic labelling and package leaflets;
Amendment 582 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to developexplore an early warning system for drug shortages based on existing structures, based on a European information network on supply problems, to increase public- private collaboration and to monitor the obligation on the part of industryall relevant supply chain stakeholders to provide early and transparent information on the availability of medicinesrelevant factors, including but not limited to the availability of medicines, demand for medicines, parallell trade activities and market distortions without undue regulatory burden; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;
Amendment 604 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Invites the Commission to evaluate which medicinal products have to go through a mandatory centralized approval at EMA in order to ensure a safe and efficient approval procedure for the most innovative and complex medicinal products, including nanomedicines;
Amendment 708 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness, in order to makpreserve the pharmaceutical sector as a strategic pillar of the EU;